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Empirical Use of Fluconazole in Critically Ill Patients: Good Study, but What Was the Hold-up?
- Mindy Schuster, MD;
- Helene Panzer, PhD; and
- John Edwards, MD
- From the University of Pennsylvania Medical Center, Philadelphia, PA 19104; Pfizer, New York, NY 10017; and Harbor University of California Los Angeles Medical Center, Torrance, CA 90502.
IN RESPONSE:
We appreciate the readers' interest in our study. Dr. Shelburne and Dr. Lee bring up the very important issue of publication delay. Some of the delays that occurred in the reporting of this trial—and in other, similarly complex, multicentered clinical trials conducted in critically ill patient populations—are invariably due to the difficulties in completing the data set after the final patient is enrolled. Performance of quality assurance, data cleaning, site answers to data queries, and review of each individual case by a busy data review committee can be cumbersome and time-intensive processes, which clearly took too long in our study. A study …
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